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| Name | Class |
|---|---|
| HLS Therapeutics, Inc | UNKNOWN |
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The REDUCE-IT Canada SA Study is a cross-sectional study aiming to determine the proportion of study participants who meet the Health Canada-approved indication for icosapent ethyl (IPE;Vascepa®).
Global derived data indicate that compared to most ethnicities, people of South Asian (SA) descent shoulder a heavier burden and mortality rate for atherosclerotic cardiovascular disease (ASCVD). They are younger at the time of first hospitalization for heart failure and exhibit more high-risk features upon discharge. Canadian data indicate that SAs presented to the hospital later during acute myocardial infarction and are more likely to have an anterior location of infarction. They also tend to be younger at the time of cardiac catheterization than those of European descent and are more likely to have significant left main, multivessel, and distal coronary artery disease. SAs appear to have comparatively pro-atherosclerotic lipid profiles - more small dense LDL particles, lower HDL-C levels, and hypertriglyceridemia - and demonstrate a higher prevalence of diabetes, metabolic syndrome, central adiposity and inflammation.
People of SA descent are markedly underrepresented in clinical trials, and it remains unclear as to whether many of the life-saving therapies are generalizable to this population. The REDUCE-IT Canada SA Study aims to determine the generalizability of the REDUCE-IT study results to people of South Asian descent with known ASCVD living in Canada. Specifically, the study will ascertain the proportion of South Asian individuals that meet the Health Canada indication for IPE; the alignment of the participants' baseline characteristics with those of the REDUCE-IT cohort; the proportion of study participants who have access to private and/or public coverage.
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| Measure | Description | Time Frame |
|---|---|---|
| Proportion of study participants who meet the Health Canada-approved indication for icosapent ethyl [Product Monograph dated Dec 30, 2019] | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of study participants whose demographic and biochemical data align with the corresponding baseline criteria of the REDUCE-IT cohort | 8 weeks | |
| Proportion of study participants who have access to private and/or public coverage | 8 weeks |
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Inclusion Criteria:
Adults 45 years of age or older of SA descent i. A person of SA descent is any individual who self-identifies as Anglo-Indian, Bangladeshi, Bengali, Bhutanese, Goan, Gujarati, Indian, Jatt, Kashmiri, Maharashtrian, Malayali, Nepali, Pakistani, Punjabi, Sindhi, Sinhalese, Sri Lankan, Tamil, Telugu, or other SA descent
History of ASCVD within the preceding 10 years defined as:
i. Documented CAD (defined as having experienced a prior MI, coronary artery bypass grafting, percutaneous coronary intervention) ii. Documented cerebrovascular disease (defined as having experienced a prior stroke, transient ischemic attack or carotid revascularization) iii. Documented peripheral artery disease (ankle-brachial index <0.9, or peripheral revascularization)
On stable statin therapy
Has had routine bloodwork within 3 years prior to enrolment- Willing and able to provide verbal or written informed consent
Exclusion Criteria:
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Participants will be identified from primary care and cardiology outpatient clinics in the Greater Toronto Area using paper-based and electronic medical records.
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| Name | Affiliation | Role |
|---|---|---|
| Subodh Verma, MD, PhD | Unity Health Toronto | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Scarborough Health Network | Ajax | Ontario | L1Z 0B1 | Canada | ||
| Fenton Medical Centre |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33172687 | Background | Gupta M. Addressing atherosclerotic cardiovascular disease risk in South Asians: A daunting task ahead. Atherosclerosis. 2020 Dec;315:76-78. doi: 10.1016/j.atherosclerosis.2020.10.892. Epub 2020 Nov 4. No abstract available. | |
| Background | Statistics Canada. Canada [Country] and Ontario [Province] (table). Census Profile. 2016 Census.2017 January 29, 2022. Available from: https://www12.statcan.gc.ca/census-recensement/2016/dp-pd/prof/index.cfm?Lang=E. | ||
| 8908818 |
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| Markham |
| Ontario |
| L3R 7B4 |
| Canada |
| North York Diagnostic and Cardiac Centre | North York | Ontario | M6B1N6 | Canada |
| Legacy Medical Centre | Scarborough Village | Ontario | M1B 5K9 | Canada |
| Diagnostic Assessment Centre | Scarborough Village | Ontario | M1S4N6 | Canada |
| Background |
| Enas EA, Garg A, Davidson MA, Nair VM, Huet BA, Yusuf S. Coronary heart disease and its risk factors in first-generation immigrant Asian Indians to the United States of America. Indian Heart J. 1996 Jul-Aug;48(4):343-53. |
| 3140974 | Background | McKeigue PM, Marmot MG. Mortality from coronary heart disease in Asian communities in London. BMJ. 1988 Oct 8;297(6653):903. doi: 10.1136/bmj.297.6653.903. No abstract available. |
| 2021718 | Background | Balarajan R. Ethnic differences in mortality from ischaemic heart disease and cerebrovascular disease in England and Wales. BMJ. 1991 Mar 9;302(6776):560-4. doi: 10.1136/bmj.302.6776.560. |
| 1529952 | Background | Enas EA, Yusuf S, Mehta JL. Prevalence of coronary artery disease in Asian Indians. Am J Cardiol. 1992 Oct 1;70(9):945-9. doi: 10.1016/0002-9149(92)90744-j. No abstract available. |
| 15860982 | Background | Superko HR, Enas EA, Kotha P, Bhat NK, Garrett B. High-density lipoprotein subclass distribution in individuals of Asian Indian descent: the National Asian Indian Heart Disease Project. Prev Cardiol. 2005 Spring;8(2):81-6. doi: 10.1111/j.1520-037x.2005.3766.x. |
| 21949711 | Background | Bhardwaj S, Misra A, Misra R, Goel K, Bhatt SP, Rastogi K, Vikram NK, Gulati S. High prevalence of abdominal, intra-abdominal and subcutaneous adiposity and clustering of risk factors among urban Asian Indians in North India. PLoS One. 2011;6(9):e24362. doi: 10.1371/journal.pone.0024362. Epub 2011 Sep 20. |
| 32990901 | Background | Banerjee AT, Shah B. One Size Does Not Fit All: Diabetes Prevalence Among Immigrants of the South Asian Diaspora. J Immigr Minor Health. 2021 Aug;23(4):653-658. doi: 10.1007/s10903-020-01093-4. Epub 2020 Sep 29. |
| 36630964 | Derived | Krishnaraj A, Bakbak E, Teoh H, Bhatt DL, Quan A, Puar P, Lambotharan B, Kirubaharan A, Firoz IN, Meglis G, Yanagawa B, Bari B, Kirubaharan R, Vijayaraghavan R, Hess DA, Demchuk AM, Mancini GBJ, Tanguay JF, Tardif JC, Voisine P, Leiter LA, Verma S. Generalizability of the REDUCE-IT trial to South Asians with cardiovascular disease. Med. 2023 Feb 10;4(2):130-138.e1. doi: 10.1016/j.medj.2022.12.008. Epub 2023 Jan 10. |
| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
| D050197 | Atherosclerosis |
| D009203 | Myocardial Infarction |
| D003327 | Coronary Disease |
| ID | Term |
|---|---|
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
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